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The rapid progress both wearable devices for self-monitoring
and DTC diagnostic apps are experiencing clearly suggests
the urgency to improve the methodologies adopted for their
performance assessment. Research should accelerate on the
investigation of the metrological characteristics, to provide
customers with all of the parameters needed for a deep evaluation
and a conscious choice among the several options offered
by the market. There is a need for sound methodologies of testing
and validation, delivering homogeneous and comparable
results that really qualify a device (whether it is a wearable
device or a DTC diagnostic app) from a metrological point
of view, reporting its accuracy and also the uncertainty of the
method used for the evaluation. Stakeholders' expertise could
be exploited to build collaborative teams who provide advice
on how to establish standard evaluation methodologies.
In conclusion, it is extremely important to define common
standards for the characterization of these monitoring and diagnostic
devices, specifying all of the quantities to be reported
when testing such instruments, such as the used reference instrumentation,
the test protocol adopted, the characteristics of
the statistical sample, the measured quantities, and the related
measurement uncertainties, in addition to the parameters that
quantify the device performance (e.g., absolute percentage error
and correlation coefficient or sensitivity and specificity for
wearable devices and diagnostic apps, respectively). The adopted
methodologies should be validated and standardized to
guarantee appropriate evaluations, using established criteria
and reporting defined parameters that classify the devices from
a metrological point of view, hence providing an evidence base
that is aligned with the requirements coming from different users,
that is patients, clinicians, researchers, entrepreneurs, and
policy makers. Furthermore, it is important that clinical trials and
systematic reviews performed by experts in the field regularly
provide information for the so-called evidence-based medicine.
References
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[8] Y. Weizman, A. M. Tan, and F. F. Konstantin, " Use of wearable
technology to enhance response to the COVID-19 pandemic, "
Public Health, Jul. 2020.
[9] L. Scalise and G. Cosoli, " Wearables for health and fitness:
measurement characteristics and accuracy, " in Proc. I2MTC 2018
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Horizons in Instrumentation and Measurement, pp. 1-6, 2018.
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Gloria Cosoli (g.cosoli@staff.univpm.it) is a Postdoc Research
Fellow in the Department of Industrial Engineering
and Mathematical Sciences (DIISM) at the Marche Polytechnic
University, Ancona, Italy (UNIVPM). She received the Ph.D.
degree in mechanical engineering from UNIVPM in 2017. Her
research focuses on non-obtrusive physiological and mechanical
measurements, numerical modelling, signal processing,
and NDTs.
IEEE Instrumentation & Measurement Magazine
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